Influence of GanedenBC30 (Bacillus Coagulans GBI-30, 6086) on the Gut Microbiome in Healthy Adults

NCT02872688 | Completed

• 1 other identifier: GANERPD-160001-RPD01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic bacteria (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults. Subjects will complete a 2-week run-in period prior to receiving GanedenBC30. The study is open-label and subjects will act as their own controls as the microbiome is unique to individuals. During the run-in period, subjects will collect two stool samples and complete daily bowel habit diaries in order to understand usual habits and profile the microbiome for each subject. 30 subjects will take part in this research study conducted at Nutrasource Diagnostics Inc. Subjects will take GanedenBC30 for four weeks. Stool samples will be collected at the end of the study and daily bowel habit diaries maintained for the duration of the study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Changes in the gut microbiome

  Observe changes in the gut microbiome after 4 weeks of supplementation with GanedenBC30 as assessed by 16s RNA sequencing of feces

  4 weeks

Secondary Outcomes (6)

• Change in stool frequency

  4 weeks

• Change in stool consistency

  4 weeks

• Changes severity of bloating as assessed by daily scores using a 4 point Likert scale

  4 weeks

• Changes severity of gas as assessed by daily scores using a 4 point Likert scale

  4 weeks

• Changes severity of abdominal pain as assessed by daily scores using a 4 point Likert scale

  4 weeks

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by MedDRA coding

  4 weeks

Study Arms (1)

GanedenBC30

EXPERIMENTAL

Other: GanedenBC30

Interventions

GanedenBC30 OTHER

Also known as: Bacillus coagulans GBI-30, 6086

GanedenBC30

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoker, or ex-smoker ≥6 months
• Body mass index 18.5- 34.9 kg/m2 (inclusive)
• Female subjects of childbearing potential \[i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)\] must have negative urine pregnancy test and must be using an effective birth control method
• Willing to avoid alcohol consumption for 24 h prior to every clinic visit
• Willing to maintain their regimens of dietary supplements known to alter GI function (including, but not limited to, iron supplements and calcium)
• Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed
• Willing and able to provide informed written consent

You may not qualify if:

• Pregnancy or lactation, or subject unwilling to take appropriate contraceptives for the duration of the study
• Use of prescription drugs (other than birth control) within 1 month prior to visit 1b
• Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 3 months prior to visit 1b
• Use of over-the-counter or prescription laxatives or stool softeners within 1 month prior to visit 1b
• Use of antibiotics (other than topical) within 2 months prior to visit 1b
• Use of prebiotic supplements (e.g. fructans and galacto-oligosaccharides (GOS), psyllium, fiber, inulin) or probiotic supplements (i.e. live microorganisms) within 1 month of visit 1b or consumption of any yogurts or foods with added prebiotics or added probiotics within 2 weeks of visit 1b
• History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
• Individuals with achlorhydria
• Presence of any disease (including, but not limited to: diabetes, gastrointestinal disease, cardiovascular disease, pancreatic, renal, or liver disease, chronic diarrhea or constipation, irritable bowel syndrome, or inflammatory bowel disease
• Abdominal or gastrointestinal surgery within the previous 12 months or planned abdominal or gastrointestinal surgery in the next 4 months
• Recent gastrointestinal food-borne illness (within 1 month prior to visit 1b)
• History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.)
• History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years
• Controlled or uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
• Abnormal laboratory test results of clinical significance, including, but not limited to ALT or AST ≥1.5X the upper limit of normal at screening

Sponsors & Collaborators

• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: lead
• Ganeden Biotech, Inc.: collaborator

Study Sites (1)

Nutrasource Diagnostics Inc.

Guelph, Ontario, N1G 0B4, Canada

Location

Study Officials

• Anthony Bier, MD

  Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 19, 2016
• Study Start: August 1, 2016
• Primary Completion: December 19, 2016
• Study Completion: April 13, 2017
• Last Updated: September 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)